SAS CDM Online Training From India

 SAS CDM Online Training Course Content

A CDMS (Clinical Data Management System) is the tool utilized in the clinical research for managing clinical trial data. The data of clinical trial gathered with investigator site within case report type are stored within CDMS. For reducing the error’s possibility because of human entry, systems employ different means to authenticate the data.

Adithyaelearning provides SAS CDM online Training to the candidates having knowledge in the SAS. Throughout this course the participants will become qualified on the Clinical programming models as well as their usage in field of clinical research. The center areas for the course incorporate data integration, data manipulation, data listings production, figures and tables as per Statistical Examination Plan, as well as generation of reports and graphs. Besides this participants can be trained based on fundamental principles as well as concepts in the statistical methodology as well as clinical trials.

Import and Export Clinical Trials Data

 Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).

Manage Clinical Trials Data

 Access DICTIONARY Tables using the SQL procedure.
 Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc)

Manage Clinical Trials Data

 Access DICTIONARY Tables using the SQL procedure.
 Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).

Apply Statistical Procedures for Clinical Trials

 Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE,
MEANS, SUMMARY).
 Use PROC FREQ to obtain p-values for categorical data (2×2 and NxP test for association).
 Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample ttests).
 Create output data sets from statistical procedures.

Validate Clinical Trial Data Reporting

 Explain the principles of programming validation in the clinical trial industry.
 Utilize the log file to validate clinical trial data reporting.
 Use programming techniques to validate clinical trial data reporting (PROC COMPARE,
MSGLEVEL).
 Identify and Resolve data, syntax and logic errors.

Macro Programming for Clinical Trials

 Create and use user-defined and automatic macro variables.
 Automate programs by defining and calling macros.
 Use system options to debug macros and display values of macro variables in the SAS log
(MPRINT, SYMBOLGEN, MLOGIC, MACROGEN).

Report Clinical Trials Results

 Use PROC REPORT to produce tables and listings for clinical trials reports.
 Use ODS and global statements to produce and augment clinical trials reports.

Clinical Trials Process;

 Describe the clinical research process (phases, key roles, key organizations).
 Interpret a Statistical Analysis Plan.
 Derive programming requirements from an SAP and an annotated Case Report Form.
 Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on
Harmonization, Good Clinical Practices)

Clinical Trials Data Structures

 Describe the structure and purpose of the CDISC ADaM data model.
 Describe the contents and purpose of define.xml.
 Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication,
etc.).
 Identify key CDISC principals and terms.
 Describe the structure and purpose of the CDISC SDTM data model.

Clinical Data Management Course Content;

 Components of SAS Different data types
 Base/SAS
 SAS/STAT
 SAS/Graph
 SAS/ACCESS
 SAS procedures
 SAS Procedures
 SAS Macros
 SAS (working with sql)
 Open clinical
 Data management
 Study planning
 Study design
 Oracle clinical (overview)

Data base design

 Protocol planning
 CRF Data entry

Clinical Trails and Clinical Data Management :

 Pharmacokinetics
 Pharmacovigilance
 Clinical data management process
 CDISC introduction
 CTM systems
 Data management plan
 Phase trails: preclinical1,2,3 and 4
 Drug discovery and development
 ICH GCP
 Computer system validation
 21 CFR 11
 CRF designing

Sub Chapter

 Introduction to SAS in CDM
 Informed consent form
 ICH history
 GPC guidelines
 FDA history
 FDA guidelines
 IND,NDA reviews
 Clinical research study document
 CRF reviews and sample CRF’s
 CRF data submission
 CRF receiving
 General abbreviated terms
 Introduction to clinical trails
 Responsibilities of CRA
 Activities of CRA in house
 CRA monitoring
 Clinical trail monitoring
 Responsibilities of PI
 IRB

At Adithyaelearning we provide finest SAS clinical research online or the SAS CDM online training through offering hands-on workshops, environment of dedicated training away from the office distractions, as well as our tutors are positioned at worldwide locations as per your domestic timings.

Contact Information ;
SKYPE ID: adithyaelearning
Contact : +91 8790679998, 9848371343
EMAIL : adithyaelearning@gmail.com , info@adithyaelearning.com